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Teva Receives Approvable Letter for AGILECT 'Rasagiline'
- Jul 05 2004
Teva Pharmaceutical Industries Ltd. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for once-daily AGILECT(R) (rasagiline mesylate) as a treatment for Parkinson's disease as monotherapy in early PD patients and as adjunct therapy to levodopa in moderate-to-advanced stages of the disease. Following the approvable letter, Teva will work with the FDA to complete the process of receiving final approval as soon as possible.
Israel Makov, President and CEO of Teva commented: "We are very pleased to receive this approvable letter, which is a major regulatory milestone in the approval process of AGILECT(R)." Mr. Makov added, "Today represents another important step towards Teva being able to offer a new treatment option to the many patients who currently suffer from Parkinson's disease in the United States."
Teva Neuroscience, Inc. and Eisai Inc. will co-promote AGILECT(R) in the U.S. once approved by the FDA.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies in the world. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Close to 90 percent of Teva's sales are in North America and Europe. Teva's R&D focuses on developing novel drugs for diseases of the central nervous system.
Source Date: Jul 05 2004
Source Publication: BUSINESS WIRE